AN ACT

 1-1     relating to the regulation of pharmacies and pharmacists; providing

 1-2     a penalty.

 1-3           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

 1-4           SECTION 1.  Section 5, Texas Pharmacy Act (Article 4542a-1,

 1-5     Vernon's Texas Civil Statutes), is amended to read as follows:

 1-6           Sec. 5.  DEFINITIONS.   In this Act, unless the context of

 1-7     its use clearly indicates otherwise:

 1-8                 (1)  "A.C.P.E." means the American Council on

 1-9     Pharmaceutical Education.

1-10                 (2)  "Administer" means the direct application of a

1-11     prescription drug by injection, inhalation, ingestion, or any other

1-12     means to the body of a patient by:

1-13                       (A)  a practitioner, an authorized agent under

1-14     his supervision, or other person authorized by law; or

1-15                       (B)  the patient at the direction of a

1-16     practitioner.

1-17                 (3)  "Administrative Procedure Act" means Chapter 2001,

1-18     Government Code [the Administrative Procedure and Texas Register

1-19     Act, as amended (Article 6252-13a, Vernon's Texas Civil Statutes)].

1-20                 (4)  "Board" means the Texas State Board of Pharmacy.

1-21                 (5)  "Class A pharmacy license" or "community pharmacy

1-22     license" means a license issued to a pharmacy dispensing drugs or

1-23     devices to the general public pursuant to a prescription drug

 2-1     order.

 2-2                 (6)  "Class B pharmacy license" or "nuclear pharmacy

 2-3     license" means a license issued to a pharmacy dispensing or

 2-4     providing radioactive drugs or devices for administration to an

 2-5     ultimate user.

 2-6                 (7)  "Class C pharmacy license" or "institutional

 2-7     pharmacy license" means a license issued to a pharmacy located in a

 2-8     hospital or other in-patient facility that is licensed under

 2-9     Chapter 241, Health and Safety Code, or Chapter 6, Texas Mental

2-10     Health Code (Article 5547-1 et seq., Vernon's Texas Civil

2-11     Statutes), to a hospice in-patient facility that is licensed under

2-12     Chapter 142, Health and Safety Code, or to a pharmacy located in a

2-13     hospital maintained or operated by the state.

2-14                 (8)  "Class D pharmacy license" or "clinic pharmacy

2-15     license" means a license issued to a pharmacy dispensing a limited

2-16     type of drugs or devices pursuant to a prescription drug order.

2-17                 (9)  "Class E pharmacy license" or "nonresident

2-18     pharmacy license" means a license issued under this Act to a

2-19     pharmacy located in a state of the United States other than this

2-20     state whose primary business is to dispense a prescription drug or

2-21     device under a prescription drug order and to deliver the drug or

2-22     device to a patient, including a patient in this state, by the

2-23     United States mail, a common carrier, or a delivery service.

2-24                 (10) [(11)]  "College of pharmacy" means a school,

2-25     university, or college of pharmacy that satisfies the accreditation

 3-1     standards of A.C.P.E. as adopted by the board; or that has degree

 3-2     requirements which meet the standards of accreditation set by the

 3-3     board.

 3-4                 (11) [(12)]  "Compounding" means the preparation,

 3-5     mixing, assembling, packaging, or labeling of a drug or device:

 3-6                       (A)  as the result of a practitioner's

 3-7     prescription drug order or initiative based on the

 3-8     practitioner-patient-pharmacist relationship in the course of

 3-9     professional practice;

3-10                       (B)  in anticipation of prescription drug orders

3-11     based on routine, regularly observed prescribing patterns; or

3-12                       (C)  for the purpose of or as an incident to

3-13     research, teaching, or chemical analysis and not for sale or

3-14     dispensing.

3-15                 (12) [(13)]  "Confidential record" means any

3-16     health-related record that contains information that identifies an

3-17     individual and that is maintained by a pharmacy or pharmacist such

3-18     as a patient medication record, prescription drug order, or

3-19     medication order.

3-20                 (13) [(14)]  "Controlled substance" means a drug,

3-21     immediate precursor, or other substance listed in Schedules I-V or

3-22     Penalty Groups 1-4 of Chapter 481, Health and Safety Code, or a

3-23     drug, immediate precursor, or other substance included in Schedule

3-24     I, II, III, IV, or V of the Federal Comprehensive Drug Abuse

3-25     Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).

 4-1                 (14) [(15)]  "Controlled Substances Act" means Chapter

 4-2     481, Health and Safety Code, or the Federal Comprehensive Drug

 4-3     Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et

 4-4     seq.).

 4-5                 (15) [(16)]  "Dangerous drug" means any drug or device

 4-6     that is not included in Penalty Groups 1-4 of the Controlled

 4-7     Substances Act and that is unsafe for self-medication or any drug

 4-8     or device that bears or is required to bear the legend:

 4-9                       (A)  "Caution:  federal law prohibits dispensing

4-10     without prescription"; or

4-11                       (B)  "Caution:  federal law restricts this drug

4-12     to use by or on the order of a licensed veterinarian."

4-13                 (16) [(17)]  "Dangerous Drug Act" means Chapter 483,

4-14     Health and Safety Code.

4-15                 (17) [(18)]  "Deliver" or "delivery" means the actual,

4-16     constructive, or attempted transfer of a prescription drug or

4-17     device or controlled substance from one person to another, whether

4-18     or not for a consideration.

4-19                 (18) [(19)]  "Designated agent" means:

4-20                       (A)  a licensed nurse, physician assistant,

4-21     pharmacist, or other individual designated by a practitioner, and

4-22     for whom the practitioner assumes legal responsibility, who

4-23     communicates prescription drug orders to a pharmacist;

4-24                       (B)  a licensed nurse, physician assistant, or

4-25     pharmacist employed in a health care facility to whom the

 5-1     practitioner communicates a prescription drug order; or

 5-2                       (C)  a registered nurse or physician assistant

 5-3     authorized by a practitioner to carry out a prescription drug order

 5-4     for dangerous drugs under Subdivision (5) or (6), Subsection (d),

 5-5     Section 3.06, Medical Practice Act (Article 4495b, Vernon's Texas

 5-6     Civil Statutes).

 5-7                 (19) [(20)]  "Device" means an instrument, apparatus,

 5-8     implement, machine, contrivance, implant, in vitro reagent, or

 5-9     other similar or related article, including any component part or

5-10     accessory, that is required under federal or state law to be

5-11     ordered or prescribed by a practitioner.

5-12                 (20) [(21)]  "Dispense" means preparing, packaging,

5-13     compounding, or labeling for delivery a prescription drug or device

5-14     in the course of professional practice to an ultimate user or his

5-15     agent by or pursuant to the lawful order of a practitioner.

5-16                 (21) [(22)]  "Distribute" means the delivery of a

5-17     prescription drug or device other than by administering or

5-18     dispensing.

5-19                 (22) [(23)]  "Drug" means:

5-20                       (A)  a substance recognized as drugs in the

5-21     current official United States Pharmacopoeia, official National

5-22     Formulary, official Homeopathic Pharmacopoeia, or other drug

5-23     compendium or any supplement to any of them;

5-24                       (B)  a substance intended for use in the

5-25     diagnosis, cure, mitigation, treatment, or prevention of disease in

 6-1     man or other animals;

 6-2                       (C)  a substance, other than food, intended to

 6-3     affect the structure or any function of the body of man or other

 6-4     animals;

 6-5                       (D)  a substance intended for use as a component

 6-6     of any articles specified in Paragraph (A), (B), or (C) of this

 6-7     subdivision;

 6-8                       (E)  a dangerous drug; or

 6-9                       (F)  a controlled substance.

6-10                 (23) [(24)]  "Drug regimen review" includes the

6-11     following activities:

6-12                       (A)  evaluation of prescription drug or

6-13     medication orders and patient medication records for:

6-14                             (i)  known allergies;

6-15                             (ii)  rational therapy-contraindications;

6-16                             (iii)  reasonable dose and route of

6-17     administration; and

6-18                             (iv)  reasonable directions for use;

6-19                       (B)  evaluation of prescription drug or

6-20     medication orders and patient medication records for duplication of

6-21     therapy;

6-22                       (C)  evaluation of prescription drug or

6-23     medication orders and patient medication records for:

6-24                             (i)  drug-drug interactions;

6-25                             (ii)  drug-food interactions;

 7-1                             (iii)  drug-disease interactions;

 7-2                             (iv)  adverse drug reactions; and

 7-3                       (D)  evaluation of prescription drug and

 7-4     medication orders and patient medication records for proper

 7-5     utilization, including overutilization or underutilization.

 7-6                 (24) [(25)]  "Internship" means a practical experience

 7-7     program that is approved by the board.

 7-8                 (25) [(26)]  "Label" means written, printed, or graphic

 7-9     matter on the immediate container of a drug or device.

7-10                 (26) [(27)]  "Labeling" means the process of affixing a

7-11     label including all information required by federal and state law

7-12     or regulation to any drug or device container.  The term does not

7-13     include the labeling by a manufacturer, packer, or distributor of a

7-14     nonprescription drug or commercially packaged prescription drug or

7-15     device, or unit dose packaging.

7-16                 (27) [(28)]  "Manufacturing" means the production,

7-17     preparation, propagation, conversion, or processing of a drug or

7-18     device, either directly or indirectly, by extraction from

7-19     substances of natural origin or independently by means of chemical

7-20     or biological synthesis and includes any packaging or repackaging

7-21     of the substances or labeling or relabeling of the container and

7-22     the promotion and marketing of such drugs or devices.

7-23     Manufacturing also includes the preparation and promotion of

7-24     commercially available products from bulk compounds for resale by

7-25     pharmacies, practitioners, or other persons but does not include

 8-1     compounding.

 8-2                 (28) [(29)]  "Medication order" means an order from a

 8-3     practitioner or a practitioner's designated agent for

 8-4     administration of a drug or device.

 8-5                 (29) [(30)]  "Nonprescription drug" means a nonnarcotic

 8-6     drug or device that may be sold without a prescription and that is

 8-7     labeled and packaged in compliance with applicable state or federal

 8-8     law.

 8-9                 (30) [(31)]  "Patient counseling" means the

8-10     communication by the pharmacist of information, as specified in the

8-11     rules of the board, to the patient or caregiver, in order to

8-12     improve therapy by ensuring proper use of drugs and devices.

8-13                 (31) [(32)]  "Person" means an individual, corporation,

8-14     government or governmental subdivision or agency, business trust,

8-15     estate, trust, partnership, association, or any other legal entity.

8-16                 (32) [(33)]  "Pharmaceutical care" is the provision of

8-17     drug therapy and other pharmaceutical services defined in the rules

8-18     of the board and intended to assist in the cure or prevention of a

8-19     disease, elimination or reduction of a patient's symptoms, or

8-20     arresting or slowing of a disease process.

8-21                 (33) [(34)]  "Pharmacist" means a person licensed by

8-22     the board to practice pharmacy.

8-23                 (34) [(35)]  "Pharmacist-in-charge" means the

8-24     pharmacist designated on a pharmacy license as the pharmacist who

8-25     has the authority or responsibility for a pharmacy's compliance

 9-1     with laws and rules pertaining to the practice of pharmacy.

 9-2                 (35) [(36)]  "Pharmacist-intern" means an undergraduate

 9-3     student enrolled in the professional sequence of a college of

 9-4     pharmacy approved by the board and participating in a school-based,

 9-5     board-approved internship program or a graduate of a college of

 9-6     pharmacy who is participating in a board-approved internship.

 9-7                 (36) [(37)]  "Pharmacy" means a facility at which

 9-8     prescription drug or medication orders are received, processed, or

 9-9     dispensed under this Act, the Dangerous Drug Act, or the Controlled

9-10     Substances Act.  The term does not include a narcotic drug

9-11     treatment program that is regulated by Chapter 466, Health and

9-12     Safety Code [licensed by the board pursuant to Section 29 of this

9-13     Act].

9-14                 (37)  "Pharmacy technician" means an individual

9-15     employed by a pharmacy whose responsibility is to provide technical

9-16     services that do not require professional judgment regarding the

9-17     preparation and distribution of drugs and who works under the

9-18     direct supervision of and is responsible to a pharmacist.

9-19                 (38)  "Practice of pharmacy" means:

9-20                       (A)  provision of those acts or services

9-21     necessary to provide pharmaceutical care;

9-22                       (B)  interpretation and evaluation of

9-23     prescription drug orders or medication orders;

9-24                       (C)  participation in drug and device selection

9-25     as authorized by law, drug administration, drug regimen review, or

 10-1    drug or drug-related research;

 10-2                      (D)  provision of patient counseling;

 10-3                      (E)  responsibility for:

 10-4                            (i)  dispensing of prescription drug orders

 10-5    or distribution of medication orders;

 10-6                            (ii)  compounding and labeling of drugs and

 10-7    devices, except labeling by a manufacturer, repackager, or

 10-8    distributor of nonprescription drugs and commercially packaged

 10-9    prescription drugs and devices;

10-10                            (iii)  proper and safe storage of drugs and

10-11    devices; or

10-12                            (iv)  maintenance of proper records for

10-13    drugs and devices; or [and]

10-14                      (F)  performance of a specific act of drug

10-15    therapy management for a patient delegated to a pharmacist by a

10-16    written protocol from a physician licensed in this state in

10-17    compliance with the Medical Practice Act (Article 4495b, Vernon's

10-18    Texas Civil Statutes).

10-19                (39)  "Practitioner" means:

10-20                      (A)  a physician, dentist, podiatrist,

10-21    veterinarian, or other person licensed or registered to prescribe,

10-22    distribute, administer, or dispense a prescription drug or device

10-23    in the course of professional practice in this state;

10-24                      (B)  a person licensed by another state in a

10-25    health field in which, under Texas law, licensees in this state may

 11-1    legally prescribe dangerous drugs or a person practicing in another

 11-2    state and licensed by another state as a physician, dentist,

 11-3    veterinarian, or podiatrist, having a current Federal Drug

 11-4    Enforcement Administration registration number, and who may legally

 11-5    prescribe Schedule II, III, IV, or V controlled substances in such

 11-6    other state; or

 11-7                      (C)  a person licensed in the Dominion of Canada

 11-8    or the United Mexican States in a health field in which, under the

 11-9    laws of this state, a licensee may legally prescribe dangerous

11-10    drugs.  "Practitioner" does not include a person licensed under

11-11    this Act.

11-12                (40)  "Preceptor" means a pharmacist [in good standing]

11-13    licensed in this state to practice pharmacy who meets the preceptor

11-14    requirements specified by rule and who is certified by the board to

11-15    supervise and be responsible for the activities and functions of a

11-16    pharmacist-intern in the internship program.

11-17                (41)  "Prescription drug" means:

11-18                      (A)  a substance for which federal or state law

11-19    requires a prescription before it may be legally dispensed to the

11-20    public;

11-21                      (B)  a drug or device that under federal law is

11-22    required, prior to being dispensed or delivered, to be labeled with

11-23    either of the following statements:

11-24                            (i)  "Caution:  federal law prohibits

11-25    dispensing without prescription"; or

 12-1                            (ii)  "Caution:  federal law restricts this

 12-2    drug to use by or on the order of a licensed veterinarian"; or

 12-3                      (C)  a drug or device that is required by any

 12-4    applicable federal or state law or regulation to be dispensed on

 12-5    prescription only or is restricted to use by a practitioner only.

 12-6                (42)  "Prescription drug order" means:

 12-7                      (A)  an order from a practitioner or a

 12-8    practitioner's designated agent to a pharmacist for a drug or

 12-9    device to be dispensed; or

12-10                      (B)  an order pursuant to Subdivision (5) or (6),

12-11    Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,

12-12    Vernon's Texas Civil Statutes).

12-13                (43)  "Prospective drug use review" means a review of

12-14    the patient's drug therapy and prescription drug order or

12-15    medication order, as defined in the rules of the board, prior to

12-16    dispensing or distributing the drug.

12-17                (44)  "Provide" means to supply one or more unit doses

12-18    of a nonprescription drug or dangerous drug to a patient.

12-19                (45)  "Radioactive drug" means a drug that exhibits

12-20    spontaneous disintegration of unstable nuclei with the emission of

12-21    nuclear particles or photons, including any nonradioactive reagent

12-22    kit or nuclide generator that is intended to be used in the

12-23    preparation of any such substance.

12-24                (46)  "Substitution" means the dispensing of a drug or

12-25    a brand of drug other than that which is ordered or prescribed.

 13-1                (47)  "Texas trade association" means a nonprofit,

 13-2    cooperative association of business or professional competitors in

 13-3    this state whose purpose is to assist its members, industry, or

 13-4    profession and whose members have joined voluntarily. ["Supportive

 13-5    personnel" means those individuals utilized in pharmacies whose

 13-6    responsibility it shall be to provide technical services that do

 13-7    not require professional judgment concerned with the preparation

 13-8    and distribution of drugs under the direct supervision of and

 13-9    responsible to a pharmacist.]

13-10                (48)  "Ultimate user" means a person who has obtained

13-11    and possesses a prescription drug or device for the person's own

13-12    use or for the use of a member of the person's household or for

13-13    administering to an animal owned by the person or by a member of

13-14    the person's household.

13-15                (49)  "Unit dose packaging" means the ordered amount of

13-16    drug in a dosage form ready for administration to a particular

13-17    patient, by the prescribed route at the prescribed time, and

13-18    properly labeled with name, strength, and expiration date of the

13-19    drug.

13-20                (50)  "Written protocol" means a physician's order,

13-21    standing medical order, standing delegation order, or other order

13-22    or protocol as defined by rule of the Texas State Board of Medical

13-23    Examiners under the Medical Practice Act (Article 4495b, Vernon's

13-24    Texas Civil Statutes).

13-25          SECTION 2.  Subsection (a), Section 8, Texas Pharmacy Act

 14-1    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 14-2    read as follows:

 14-3          (a)  A licensed pharmacist member of the board:

 14-4                (1)  may not be:

 14-5                      (A)  a salaried faculty member at a college of

 14-6    pharmacy; or

 14-7                      (B)  an officer, employee, or paid consultant of

 14-8    a Texas trade association in the field of health care or a spouse

 14-9    of an officer, employee, or paid consultant; and

14-10                (2)  must at the time of his appointment:

14-11                      (A) [(1)]  be a resident of this state;

14-12                      (B) [(2)]  be licensed for the five years

14-13    immediately preceding appointment and be in good standing to engage

14-14    in the practice of pharmacy in this state; and

14-15                      (C) [(3)]  be engaged in the practice of pharmacy

14-16    in this state.

14-17          SECTION 3.  Section 8, Texas Pharmacy Act (Article 4542a-1,

14-18    Vernon's Texas Civil Statutes), is amended by adding Subsection (f)

14-19    to read as follows:

14-20          (f)  The board shall provide to its members, as often as

14-21    necessary, information regarding their qualifications for office or

14-22    employment under this Act and their responsibilities under

14-23    applicable laws relating to standards of conduct for state officers

14-24    or employees.

14-25          SECTION 4.  Subsection (c), Section 14, Texas Pharmacy Act

 15-1    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 15-2    read as follows:

 15-3          (c)  Except as otherwise provided by this subsection, all

 15-4    board meetings and hearings shall be open to the public.  The board

 15-5    may, in its discretion and in accordance with the open meetings

 15-6    law, Chapter 551, Government Code, [Chapter 271, Acts of the 60th

 15-7    Legislature, Regular Session, 1967, as amended (Article 6252-17,

 15-8    Vernon's Texas Civil Statutes),] conduct any portion of its meeting

 15-9    in executive session.  The board may in its discretion conduct

15-10    deliberations relative to licensee disciplinary actions in

15-11    executive session.  At the conclusion of its deliberations relative

15-12    to licensee disciplinary action, the board shall vote and announce

15-13    its decision relative to the licensee in open session.  The board

15-14    in executive session may conduct disciplinary hearings relating to

15-15    a pharmacist or pharmacy student who is impaired because of

15-16    chemical abuse or mental or physical illness.

15-17          SECTION 5.  Subsections (c), (d), and (f), Section 15, Texas

15-18    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

15-19    amended to read as follows:

15-20          (c)  An officer, employee, or paid consultant of a Texas

15-21    trade association in the field of health care may not be an [a

15-22    member or] employee of the board who is exempt from the state's

15-23    position classification plan or is compensated at or above the

15-24    amount prescribed by the General Appropriations Act for step 1,

15-25    salary group 17, of the position classification salary schedule.

 16-1          (d)  A person who is the spouse of an officer, manager, or

 16-2    paid consultant of a Texas trade association in the field of health

 16-3    care may not be a [board member and may not be a] board employee

 16-4    who is exempt from the state's position classification plan or is

 16-5    compensated at or above the amount prescribed by the General

 16-6    Appropriations Act for step 1, salary group 17, of the position

 16-7    classification salary schedule.

 16-8          (f)  The board shall provide to its [members and] employees,

 16-9    as often as necessary, information regarding their qualification

16-10    for office or employment under this Act and their responsibilities

16-11    under applicable laws relating to standards of conduct for state

16-12    officers or employees.

16-13          SECTION 6.  Subsections (o) and (q), Section 17, Texas

16-14    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

16-15    amended to read as follows:

16-16          (o)  The board:

16-17                (1)  shall [may] establish rules for the use of

16-18    pharmacy technicians [supportive personnel] and the duties of those

16-19    technicians [personnel] in pharmacies licensed by the board,

16-20    provided that those technicians [personnel] are responsible to and

16-21    directly supervised by a pharmacist licensed by the board; provided

16-22    however that the board may not adopt rules or regulations

16-23    establishing ratios of pharmacists to pharmacy technicians

16-24    [supportive personnel] in Class C pharmacies; and

16-25                (2)  may determine and issue standards for recognition

 17-1    and approval of training programs for pharmacy technicians and

 17-2    maintain a list of training programs that meet the standards.

 17-3          (q)  Board investigative files and all information and

 17-4    materials compiled by the board in connection with an investigation

 17-5    are confidential and are not subject to disclosure under Chapter

 17-6    552, Government Code [424, Acts of the 63rd Legislature, Regular

 17-7    Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

 17-8    Statutes)], and are not subject to disclosure, discovery, subpoena,

 17-9    or other means of legal compulsion for their release to anyone

17-10    other than the board or its employees or agents involved in

17-11    licensee discipline except that this information may be disclosed

17-12    to:

17-13                (1)  persons involved with the board in a disciplinary

17-14    action against the licensee;

17-15                (2)  pharmacist or pharmacy licensing or disciplinary

17-16    authorities of other jurisdictions;

17-17                (3)  a pharmaceutical peer review committee as outlined

17-18    in Section 27A of this Act;

17-19                (4)  law enforcement agencies; and

17-20                (5)  persons engaged in bona fide research, if all

17-21    individual-identifying information has been deleted.

17-22          SECTION 7.  Subsection (a), Section 17D, Texas Pharmacy Act

17-23    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

17-24    read as follows:

17-25          (a)  The board by rule shall adopt procedures governing:

 18-1                (1)  informal disposition of a contested case under

 18-2    Chapter 2001, Government Code [Section 13(e), Administrative

 18-3    Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

 18-4    Civil Statutes), and its subsequent amendments]; and

 18-5                (2)  informal proceedings held in compliance with

 18-6    Chapter 2001, Government Code [Section 18(c), Administrative

 18-7    Procedure and Texas Register Act (Article 6252-13a, Vernon's Texas

 18-8    Civil Statutes), and its subsequent amendments].

 18-9          SECTION 8.  Subsections (a), (f), and (g), Section 19, Texas

18-10    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

18-11    amended to read as follows:

18-12          (a)  A person may not:

18-13                (1)  dispense or distribute prescription drugs unless

18-14    he is a licensed pharmacist or is authorized by this Act to

18-15    dispense or distribute prescription drugs; or

18-16                (2)  operate a pharmacy unless he first obtains a

18-17    license to operate a pharmacy.

18-18          (f)  This Act does not apply to:

18-19                (1)  a member of the faculty of a college of pharmacy

18-20    that is recognized by the board if the faculty member is a licensed

18-21    pharmacist and performs his services for the benefit of the college

18-22    only;

18-23                (2)  [a pharmacist-intern;]

18-24                [(3)]  a person who procures prescription drugs for

18-25    lawful research, teaching, or testing and not for resale; or

 19-1                (3) [(4)]  a home and community support services agency

 19-2    that possesses a dangerous drug as authorized by Section 142.0061,

 19-3    Health and Safety Code.

 19-4          (g)  Any person found by the board to have unlawfully engaged

 19-5    in the practice of pharmacy or unlawfully operated a pharmacy is

 19-6    subject to a civil penalty under Section 37A of this Act [fine to

 19-7    be imposed by the board not to exceed $1,000 for each offense].

 19-8    Each violation of this Act or the rules adopted under this Act

 19-9    pertaining to unlawfully engaging in the practice of pharmacy or

19-10    unlawfully operating a pharmacy also constitutes a Class A

19-11    misdemeanor.

19-12          SECTION 9.  Section 20, Texas Pharmacy Act (Article 4542a-1,

19-13    Vernon's Texas Civil Statutes), is amended to read as follows:

19-14          Sec. 20.  PHARMACIST-INTERN REGISTRATION.   (a)  A person

19-15    must register with the board before beginning the board-approved

19-16    internship in this state.  An application for the registration of a

19-17    pharmacist-intern must be on a form prescribed by the board.

19-18    Registration shall remain in effect as long as the person meets the

19-19    qualifications for internship as specified by rules adopted by the

19-20    board [during internship training and thereafter until the earlier

19-21    of the following occurs:]

19-22                [(1)  the failure of the pharmacist-intern to take the

19-23    next regularly scheduled examination; or]

19-24                [(2)  the failure to pass the next regularly scheduled

19-25    examination].

 20-1          (b)  The board may in its discretion refuse to issue a

 20-2    registration to an applicant and may restrict, suspend, or revoke a

 20-3    pharmacist-intern registration for any violation of this Act.  In

 20-4    enforcing Section 26(a)(4) of this Act, the board shall, on

 20-5    probable cause, request a pharmacist-intern or pharmacist-intern

 20-6    applicant to submit to a mental or physical examination by

 20-7    physicians or other health care professionals designated by the

 20-8    board.  If the pharmacist-intern or applicant refuses to submit to

 20-9    the examination, the board shall issue an order requiring the

20-10    pharmacist-intern or applicant to show cause why he will not submit

20-11    to the examination and shall schedule a hearing on the order within

20-12    30 days after notice is served on the pharmacist-intern or

20-13    applicant.  The board shall notify the pharmacist-intern or

20-14    applicant by either personal service or certified mail with return

20-15    receipt requested.  At the hearing, the pharmacist-intern or

20-16    applicant and an attorney are entitled to present any testimony and

20-17    other evidence to show why the pharmacist-intern or applicant

20-18    should not be required to submit to the examination.  After the

20-19    hearing, the board shall issue an order either requiring the

20-20    pharmacist-intern or applicant to submit to the examination or

20-21    withdrawing the request for examination.

20-22          SECTION 10.  Subsections (a) and (e), Section 21, Texas

20-23    Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes), are

20-24    amended to read as follows:

20-25          (a)  To qualify for a license to practice pharmacy, an

 21-1    applicant for licensing by examination must submit to the board a

 21-2    license fee as determined by the board and a completed application

 21-3    on a form prescribed by the board with satisfactory sworn evidence

 21-4    that he:

 21-5                (1)  is at least 18 years old;

 21-6                (2)  is of good moral character;

 21-7                (3)  has completed a minimum of a 1,000-hour internship

 21-8    or other program that has been approved by the board or has

 21-9    demonstrated, to the board's satisfaction, experience in the

21-10    practice of pharmacy that meets or exceeds the minimum internship

21-11    requirements of the board;

21-12                (4)  has graduated and received a [the first

21-13    professional undergraduate degree or the advanced] professional

21-14    practice degree, as defined by the rules adopted by the board, from

21-15    an accredited pharmacy degree program approved by the board;

21-16                (5)  has passed the examination required by the board;

21-17    and

21-18                (6)  has not had a pharmacist license granted by

21-19    another state suspended, revoked, canceled, surrendered, or

21-20    otherwise restricted for any reason.

21-21          (e)  The [Within 30 days after the date a licensing

21-22    examination is administered under this Act, the] board shall notify

21-23    each examinee of the results of the examination[.  However, if an

21-24    examination is graded or reviewed by a national testing service,

21-25    the board shall notify each examinee of the results of the

 22-1    examination] within 30 days [two weeks] after the date the board

 22-2    receives the results from a national [the] testing service.  [If

 22-3    the notice of the examination results will be delayed for more than

 22-4    90 days after the examination date, the board shall notify the

 22-5    examinee of the reason for the delay before the 90th day.]

 22-6          SECTION 11.  Subsection (a), Section 22, Texas Pharmacy Act

 22-7    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 22-8    read as follows:

 22-9          (a)  To qualify for a license to practice pharmacy by

22-10    reciprocity, an applicant for licensing must:

22-11                (1)  submit to the board a reciprocity fee as

22-12    determined by the board and a completed application given under

22-13    oath, in the form prescribed by the board;

22-14                (2)  have good moral character;

22-15                (3)  have graduated and received a [the first

22-16    professional undergraduate degree or the advanced] professional

22-17    practice degree, as defined by the rules adopted by the board, from

22-18    an accredited pharmacy degree program approved by the board;

22-19                (4)  have possessed at the time of initial licensing as

22-20    a pharmacist other qualifications necessary to have been eligible

22-21    for licensing at that time in this state;

22-22                (5)  have presented to the board proof of initial

22-23    licensing by examination and proof that the license and other

22-24    license or licenses granted to the applicant by any other state

22-25    have not been suspended, revoked, canceled, surrendered, or

 23-1    otherwise restricted for any reason; and

 23-2                (6)  pass the Texas [Drug and] Pharmacy Jurisprudence

 23-3    examination.

 23-4          SECTION 12.  Subsection (b), Section 26, Texas Pharmacy Act

 23-5    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 23-6    read as follows:

 23-7          (b)  Grounds for Disciplining a Holder of a Pharmacy License:

 23-8    The board shall refuse to issue a pharmacy license for failure to

 23-9    meet the requirements of Section 29 or 30 of this Act.  The board

23-10    may in its discretion refuse to issue or renew a license or may

23-11    assess a penalty, reprimand, revoke, restrict, cancel, or suspend

23-12    any license granted by the board, and may probate any license

23-13    suspension if the board finds that the applicant or licensee has:

23-14                (1)  been convicted of a felony or a misdemeanor

23-15    involving moral turpitude, or if the applicant or licensee is a

23-16    legal entity such as an association, joint stock company,

23-17    partnership, or corporation, that a managing officer has been

23-18    convicted of a felony or a misdemeanor involving moral turpitude

23-19    under the law of this state, another state, or the United States;

23-20                (2)  advertised any prescription drugs or devices in a

23-21    deceitful, misleading, or fraudulent manner;

23-22                (3)  violated any provision of this Act or any rule

23-23    adopted under this Act or that any owner or employee of a pharmacy

23-24    has violated any provision of this Act or any rule adopted under

23-25    this Act;

 24-1                (4)  sold without legal authorization prescription

 24-2    drugs or devices to persons other than:

 24-3                      (A)  a pharmacy licensed by the board;

 24-4                      (B)  a practitioner;

 24-5                      (C)  a person who procures prescription drugs or

 24-6    devices for the purpose of lawful research, teaching, or testing,

 24-7    and not for resale;

 24-8                      (D)  a manufacturer or wholesaler registered with

 24-9    the commissioner of health as required by Chapter 431, Health and

24-10    Safety Code; or

24-11                      (E)  a carrier or warehouseman;

24-12                (5)  allowed an employee who is not a licensed

24-13    pharmacist to practice pharmacy;

24-14                (6)  sold adulterated or misbranded prescription or

24-15    nonprescription drugs;

24-16                (7)  failed to engage in or ceased to engage in the

24-17    business described in the application for a license;

24-18                (8)  failed to keep and maintain records as required by

24-19    this Act, the Controlled Substances Act, Dangerous Drug Act, or

24-20    rules adopted under this Act or the Dangerous Drug Act; [or]

24-21                (9)  failed to establish and maintain effective

24-22    controls against diversion of prescription drugs into other than

24-23    legitimate medical, scientific, or industrial channels as provided

24-24    by this Act or other state or federal laws or rules; or

24-25                (10)  engaged in any fraud, deceit, or

 25-1    misrepresentation as defined by the rules adopted by the board in

 25-2    operating a pharmacy or in seeking a license to operate a pharmacy.

 25-3          SECTION 13.  Subsection (c), Section 26A, Texas Pharmacy Act

 25-4    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 25-5    read as follows:

 25-6          (c)  Any disciplinary action taken by the board under this

 25-7    section is governed by the Administrative Procedure Act (Chapter

 25-8    2001, Government Code [and Texas Register Act (Article 6252-13a,

 25-9    Vernon's Texas Civil Statutes]) and the rules of practice and

25-10    procedure adopted by the board.

25-11          SECTION 14.  Section 27, Texas Pharmacy Act (Article 4542a-1,

25-12    Vernon's Texas Civil Statutes), is amended to read as follows:

25-13          Sec. 27.  PROCEDURE.   Except as provided in Section 27A of

25-14    this Act, any disciplinary action taken by the board under Section

25-15    26, 26A, or 26B of this Act is governed by the Administrative

25-16    Procedure Act (Chapter 2001, Government Code [and Texas Register

25-17    Act (Article 6252-13a, Vernon's Texas Civil Statutes]) and the

25-18    rules of practice and procedure before the board.

25-19          SECTION 15.  Subsection (d), Section 27A, Texas Pharmacy Act

25-20    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

25-21    read as follows:

25-22          (d)  The records and proceedings of the board, its authorized

25-23    agents, or any pharmaceutical organization committee as set out in

25-24    Subsections (a) and (b) of this section shall be confidential and

25-25    are not considered open records for the purposes of Chapter 552,

 26-1    Government Code [424, Acts of the 63rd Legislature, Regular

 26-2    Session, 1973, as amended (Article 6252-17a, Vernon's Texas Civil

 26-3    Statutes)]; provided, however, the board may disclose this

 26-4    confidential information only:

 26-5                (1)  in a disciplinary hearing before the board or in a

 26-6    subsequent trial or appeal of a board action or order;

 26-7                (2)  to the pharmacist licensing or disciplinary

 26-8    authorities of other jurisdictions;

 26-9                (3)  pursuant to an order of a court of competent

26-10    jurisdiction; or

26-11                (4)  pursuant to Subsection (j) of this section.

26-12          SECTION 16.  Subsection (c), Section 27B, Texas Pharmacy Act

26-13    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

26-14    read as follows:

26-15          (c)  The identity of a person who reports to or assists the

26-16    board under this section and any document that could disclose the

26-17    identity of that person is confidential and does not constitute

26-18    public information for the purposes of Chapter 552, Government Code

26-19    [424, Acts of the 63rd Legislature, Regular Session, 1973 (Article

26-20    6252-17a, Vernon's Texas Civil Statutes)].

26-21          SECTION 17.  Subsection (a), Section 28, Texas Pharmacy Act

26-22    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

26-23    read as follows:

26-24          (a)  On the finding of the existence of grounds for

26-25    discipline of any person holding a license or seeking a license or

 27-1    a renewal license under this Act, the board may impose one or more

 27-2    of the following penalties:

 27-3                (1)  suspension of the offender's license;

 27-4                (2)  revocation of the offender's license;

 27-5                (3)  restriction of the offender's license to prohibit

 27-6    the offender from performing certain acts or from engaging in the

 27-7    practice of pharmacy or operating a pharmacy in a particular manner

 27-8    for a term and under conditions to be determined by the board;

 27-9                (4)  imposition of an administrative penalty under

27-10    Section 28B of this Act;

27-11                (5)  refusal to issue or renew the offender's license;

27-12                (6)  placement of the offender's license on probation

27-13    and supervision by the board for a period to be determined by the

27-14    board and imposition of a requirement that the licensee:

27-15                      (A)  report regularly to the board on matters

27-16    that are the basis of the probation;

27-17                      (B)  limit practice to the areas prescribed by

27-18    the board; [or]

27-19                      (C)  continue or review professional education

27-20    until the licensee attains a degree of skill satisfactory to the

27-21    board in those areas that are the basis of the probation; or

27-22                      (D)  pay the board a probation fee to defray the

27-23    costs of monitoring a licensee during the period of probation;

27-24                (7)  reprimand;

27-25                (8)  cancellation of the offender's license; or

 28-1                (9)  retirement of the offender's license as provided

 28-2    by board rule[; or]

 28-3                [(10)  imposition of a civil penalty that does not

 28-4    exceed $1,000 for each day of each violation and that may be

 28-5    collected in a suit initiated by the board].

 28-6          SECTION 18.  Subsection (e), Section 29, Texas Pharmacy Act

 28-7    (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

 28-8    read as follows:

 28-9          (e)  The board shall have the discretion to determine under

28-10    which classifications a pharmacy applicant may be licensed.  With

28-11    respect to Class C pharmacies, the board may establish rules for

28-12    the use of pharmacy technicians [supportive personnel] and the

28-13    duties of those technicians [personnel] in Class C pharmacies

28-14    licensed by the board, provided that these technicians [personnel]

28-15    are responsible to and directly supervised by a pharmacist licensed

28-16    by the board; provided, however, the board may not adopt any rule

28-17    setting ratios with respect to pharmacists and pharmacy technicians

28-18    [supportive personnel] or limiting the number of pharmacy

28-19    technicians [supportive personnel] that may be utilized.

28-20          SECTION 19.  Section 35, Texas Pharmacy Act (Article 4542a-1,

28-21    Vernon's Texas Civil Statutes), is amended to read as follows:

28-22          Sec. 35.  UNLAWFUL USE OF "PHARMACY."    (a)  A person may

28-23    not display in or on any store or place of business the word

28-24    "pharmacy," either in English or any other language, any other word

28-25    or combination of words of the same or similar meaning, or any

 29-1    graphic representation that would mislead or tend to mislead the

 29-2    public unless it is a pharmacy licensed under this Act.

 29-3          (b)  A person may not advertise any store or place of

 29-4    business as a pharmacy or provide pharmacy services unless the

 29-5    facility is a pharmacy licensed under this Act.

 29-6          SECTION 20.  The Texas Pharmacy Act (Article 4542a-1,

 29-7    Vernon's Texas Civil Statutes) is amended by adding Section 37A to

 29-8    read as follows:

 29-9          Sec. 37A.  CIVIL PENALTY.  (a)  A person who violates the

29-10    license requirements of this Act is liable to the state for a civil

29-11    penalty of up to $1,000 for each day the violation continues.

29-12          (b)  At the request of the board, the attorney general shall

29-13    institute an action to collect a civil penalty from a person who

29-14    has violated this Act or rules adopted under this Act.

29-15          (c)  If the attorney general fails to take action within 30

29-16    days of referral from the board, the board shall refer the case to

29-17    the local district attorney, county attorney, or city attorney.

29-18    The district attorney, county attorney, or city attorney shall file

29-19    suit in a district court to collect and retain the penalty.

29-20          (d)  Venue for a suit under this section is in Travis County.

29-21          SECTION 21.  Section 40, Texas Pharmacy Act (Article 4542a-1,

29-22    Vernon's Texas Civil Statutes), is amended by adding Subsection (m)

29-23    to read as follows:

29-24          (m)  Except as provided by this subsection, drug product

29-25    selection authorized in this section does not apply to the refill

 30-1    of a prescription for a narrow therapeutic index drug.  The board,

 30-2    in consultation with the Texas State Board of Medical Examiners,

 30-3    shall establish, by rule, a list of narrow therapeutic index drugs

 30-4    that are subject to this subsection.  A prescription for a narrow

 30-5    therapeutic index drug may be refilled only by using the same drug

 30-6    product by the same manufacturer that the pharmacist last dispensed

 30-7    under the prescription, unless otherwise agreed to by the

 30-8    prescribing physician.  If a pharmacist does not have the same drug

 30-9    product by the same manufacturer in stock to refill the

30-10    prescription, the pharmacist may dispense a drug product that is

30-11    generically equivalent if the pharmacist, before dispensing the

30-12    generically equivalent drug product, notifies:

30-13                (1)  the patient, at the time the prescription is

30-14    dispensed, that a substitution of the prescribed drug product has

30-15    been made; and

30-16                (2)  the prescribing practitioner of the drug product

30-17    substitution by telephone, facsimile, or mail, at the earliest

30-18    reasonable time, but not later than 72 hours after dispensing the

30-19    prescription.

30-20          SECTION 22.  Subdivisions (10) and (11), Section 483.001,

30-21    Health and Safety Code, are amended to read as follows:

30-22                (10)  "Pharmacy" means a facility where prescription

30-23    drug or medication orders are received, processed, dispensed, or

30-24    distributed under this chapter, Chapter 481, and the Texas Pharmacy

30-25    Act (Article 4542a-1, Vernon's Texas Civil Statutes).  The term

 31-1    does not include a narcotic drug treatment program that is

 31-2    regulated by Chapter 466, Health and Safety Code [licensed by the

 31-3    board pursuant to Section 29, Texas Pharmacy Act (Article 4542a-1,

 31-4    Vernon's Texas Civil Statutes)].

 31-5                (11)  "Practice of pharmacy" means:

 31-6                      (A)  provision of those acts or services

 31-7    necessary to provide pharmaceutical care;

 31-8                      (B)  interpretation and evaluation of

 31-9    prescription drug orders or medication orders;

31-10                      (C)  participation in drug and device selection

31-11    as authorized by law, drug administration, drug regimen review, or

31-12    drug or drug-related research;

31-13                      (D)  provision of patient counseling; [and]

31-14                      (E)  responsibility for:

31-15                            (i)  dispensing of prescription drug orders

31-16    or distribution of medication orders in the patient's best

31-17    interest;

31-18                            (ii)  compounding and labeling of drugs and

31-19    devices, except labeling by a manufacturer, repackager, or

31-20    distributor of nonprescription drugs and commercially packaged

31-21    prescription drugs and devices;

31-22                            (iii)  proper and safe storage of drugs and

31-23    devices; or [and]

31-24                            (iv)  maintenance of proper records for

31-25    drugs and devices.  In this subdivision, "device" has the meaning

 32-1    assigned by the Texas Pharmacy Act (Article 4542a-1, Vernon's Texas

 32-2    Civil Statutes); or

 32-3                      (F)  performance of a specific act of drug

 32-4    therapy management for a patient delegated to a pharmacist by a

 32-5    written protocol from a physician licensed by the state under the

 32-6    Medical Practice Act (Article 4495b, Vernon's Texas Civil

 32-7    Statutes).

 32-8          SECTION 23.  Subsection (b), Section 483.003, Health and

 32-9    Safety Code, is amended to read as follows:

32-10          (b)  On making that finding, the Texas Board of Health

32-11    [board] may limit the availability of the abused drug by permitting

32-12    its dispensing only on the prescription of a practitioner described

32-13    by Section 483.001(12)(A) or (B).

32-14          SECTION 24.  Subsection (e), Section 483.042, Health and

32-15    Safety Code, is amended to read as follows:

32-16          (e)  The labeling provisions of Subsection (a) do not apply

32-17    to a dangerous drug prescribed or dispensed for administration to a

32-18    patient who is institutionalized.  The board shall adopt rules for

32-19    the labeling of such a drug [food production animals in an

32-20    agricultural operation under a written medical directive or

32-21    treatment guideline from a veterinarian licensed under The

32-22    Veterinary Licensing Act (Article 8890, Revised Statutes) and its

32-23    subsequent amendments].

32-24          SECTION 25.  Chapter 107, Acts of the 41st Legislature,

32-25    Regular Session, 1929 (Article 4542a, Vernon's Texas Civil

 33-1    Statutes), is repealed.

 33-2          SECTION 26.  Subsection (b), Section 26A, Texas Pharmacy Act

 33-3    (Article 4542a-1, Vernon's Texas Civil Statutes), as amended by

 33-4    Section 7, Chapter 789, Acts of the 73rd Legislature, 1993, is

 33-5    repealed.

 33-6          SECTION 27.  This Act takes effect September 1, 1997.

 33-7          SECTION 28.  (a)  This Act applies only to a license issued

 33-8    or renewed by the Texas State Board of Pharmacy on or after the

 33-9    effective date of this Act.  A license issued or renewed before

33-10    that date is governed by the law in effect on the date the license

33-11    was issued or renewed, and the former law is continued in effect

33-12    for that purpose.

33-13          (b)  Section 37A, Texas Pharmacy Act (Article 4542a-1,

33-14    Vernon's Texas Civil Statutes), as added by this Act, applies only

33-15    to a violation of the licensing requirements of the Texas Pharmacy

33-16    Act (Article 4542a-1, Vernon's Texas Civil Statutes) that occurs on

33-17    or after the effective date of this Act.

33-18          SECTION 29.  The importance of this legislation and the

33-19    crowded condition of the calendars in both houses create an

33-20    emergency and an imperative public necessity that the

33-21    constitutional rule requiring bills to be read on three several

33-22    days in each house be suspended, and this rule is hereby suspended.

         _______________________________     _______________________________

             President of the Senate              Speaker of the House

               I hereby certify that S.B. No. 609 passed the Senate on

         April 9, 1997, by a viva-voce vote; and that the Senate concurred

         in House amendments on May 29, 1997, by a viva-voce vote.

                                             _______________________________

                                                 Secretary of the Senate

               I hereby certify that S.B. No. 609 passed the House, with

         amendments, on May 27, 1997, by a non-record vote.

                                             _______________________________

                                                 Chief Clerk of the House

         Approved:

         _______________________________

                     Date

         _______________________________

                   Governor